MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESPHERE® 1.5 NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3258
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr for the second needle was submitted under mfr # 9616793-2017-00124.
Event or Problem Description
It was reported that after the first cycle was completed, the physician started to do freezing for the second cycle.They used two icesphere needles and one of them started to be thawing even though the system was in freeze mode.Although the procedure was completed, the tumor ablation was reportedly not successful.There were no known patient consequences reported.
Additional Manufacturer Narrative
The needle was returned for investigation.The manufacturing records were reviewed and no related deviation or concerns were found.The reported complaint of the needle started to be thawing even though the system was proceed in freezing was not confirmed as the needle passed all investigative tests and the iceball size was within specification.

• Brand Name: ICESPHERE® 1.5 NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam,, israel 20692 ; IS 20692
• MDR Report Key: 7008018
• Report Number: 9616793-2017-00123
• Device Sequence Number: 16368986
• Product Code: GEH
• UDI-Device Identifier: 07290104830211
• UDI-Public: 07290104830211
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K060390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/01/2019
• Device Model Number: FPRPR3258
• Device Lot Number: B8204-018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1